Lever for auto insertion and secure placement of iv tubing for use in intravenous pump systems

ABSTRACT

A lever including a far end to engage an infusion tubing is provided. The lever includes a pivot end configured to fit into a shaft and to allow the lever to rotate about a shaft axis, the pivot end including a pocket to capture a spring having a leg protruding outside. The spring is configured to apply a bias from the lever against a door assembly. The lever includes a tab disposed on an outer side of the far end and configured to interface with the door assembly, and a pusher protruding into an inner side of the far end and configured to contact the infusion tubing when the far end engages the infusion tubing. The pusher applies a downward pressure to the infusion tubing when the door assembly is closed until the infusion tubing is properly aligned with an air-in-line sensor disposed on both sides of the tubing.

CROSS-REFERENCE TO RELATED APPLICATION

This is a continuation of U.S. patent application Ser. No. 15/793,513,filed on Oct. 25, 2017, entitled “LEVER FOR AUTO INSERTION AND SECUREPLACEMENT OF IV TUBING FOR USE IN INTRAVENOUS PUMP SYSTEMS,” thedisclosure of which is hereby incorporated by reference in its entiretyfor all purposes.

BACKGROUND

The present disclosure is generally related to intravascular pumps formedication delivery to a patient. More specifically, the presentdisclosure relates to devices and methods to properly align an infusiontubing in the chassis of an infusion pump to avoid false alarms createdby misalignment between the infusion tubing and a sensor configured tomonitor the fluid delivery.

SUMMARY

In many intravascular (IV) infusion applications the Directions For Use(DFU) direct the user of an IV medication system to hand-thread theinfusion tubing into a slot in the pump casing where an air-in-line(AIL) sensor will be able to provide direct measurements of the fluid inthe infusion tubing. However, the hand-threading instruction istypically missed by many users, leading to causing excessive false AILalarms, leading to high inefficiencies in trial and error attempts toproperly place the infusion tubing in the sensor slot.

In some aspects of the disclosure, a lever is provided that includes afar end configured to engage an infusion tubing and a pivot endconfigured to fit onto a shaft and to allow the lever to rotate about ashaft axis, the pivot end comprising a pocket to capture a spring havinga leg protruding outside of the pocket, wherein the spring is configuredto bias the lever against an infusion pump door assembly. The lever alsoincludes a tab disposed on an outer side of the far end and configuredto interface with the door assembly, a pusher protruding into an innerside of the far end and configured to contact the infusion tubing whenthe far end engages the infusion tubing, wherein the pusher isconfigured to apply a downward pressure to the infusion tubing when thedoor assembly is closed until the infusion tubing is properly alignedwith an air-in-line sensor disposed on both sides of the infusiontubing.

In some aspects of the disclosure, a method of operating an infusionpump is provided. The method includes loading an infusion tubing intothe infusion pump having a lever. The method also includes closing theinfusion pump door assembly to cause the far end of the lever to pivotabout the shaft and to cause the pusher to contact and push the infusiontubing into a slot in the air-in-line sensor. The method furtherincludes activating the infusion pump when the air-in-line sensorindicates that the infusion tubing is properly aligned within the slot.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an IV casing including a door assembly and anair-in-line (AIL) sensor, according to some embodiments.

FIG. 2 illustrates a lever driven by the door assembly and configured toplace an infusion tubing in the AIL sensor housing at an appropriatedepth, according to some embodiments.

FIG. 3 is a close-up perspective view of the lever in FIG. 2, includinga captured spring for automatic unloading when the door assembly isopened, according to some embodiments.

FIG. 4 illustrates a pin configured as a bezel for the lever, accordingto some embodiments.

FIG. 5 illustrates a lever to tubing interface when the door assembly isclosed, according to some embodiments.

FIG. 6 illustrates a close-up perspective view of a door assemblyincluding reinforced ribs and guiding ribs, according to someembodiments.

FIG. 7 illustrates an intra-venous pump, according to some embodiments.

FIG. 8 is a flow chart illustrating steps in a method for delivering amedication to a patient, according to some embodiments.

In the figures, elements having the same or a similar reference numeralhave the same or similar functionality or configuration, unlessdescribed as otherwise.

DETAILED DESCRIPTION

For infusion pump applications, the proper placing of an infusion tubingwithin the pump casing is a critical step. When the infusion tubing isnot placed properly, the AIL sensor may tend to sound an alarm forimproper positioning. Accordingly, in typical prior art systems the AILsensor may generate multiple false alarms when the infusion tubing isnot properly placed within the sensitive elements in the AIL sensor.Accordingly, health care personnel may have to repeatedly accommodatethe infusion tubing to guarantee a proper medication infusion procedure.This causes inefficiencies and may create serious health care outcomeswhen a medical emergency demands quick and reliable operation.

Embodiments as disclosed herein largely mitigate the above problem byautomating the precise location of the infusion tubing in a slot of theAIL sensor to properly read an air-in-line state and avoid a false alarmactivation. A false alarm may be caused by an improper installation ofthe IV set, because a user forgets to hand-thread the IV line in the AILslot so that the alarm goes off as soon as the user closes thedoor/latch due to improper placement of the infusion tubing within theAIL housing. False alarms may occur after infusion starts, when theinfusion tubing is near the edge of the AIL sensor range, e.g., too farinside, or not far enough within the slot in the AIL sensor.Accordingly, the infusion tubing may be displaced out of the sensingarea after infusion starts due to mechanical adjustment, thus trigger afalse alarm. Embodiments as disclosed herein provide a solution to thefalse alarm problem by including a lever that pushes the tubing intoposition automatically, as a door assembly in the pump casing is closedover the infusion tubing. In addition, embodiments of the presentdisclosure include features for applying a constant strain relief to theinfusion tubing, which have the added benefit of facilitating thepositioning of the pump, and the handling of the infusion tubing withoutthe risk of inducing kinks or tears in the tubing.

Some of the advantages of embodiments consistent with the presentdisclosure include a secure and reliable mechanism for placing infusiontubing in place for IV medication delivery, and simplifying the handlingof infusion setups including infusion tubing and pumps in the vicinityof a patient.

FIG. 1 illustrates a pump casing 10 including a chassis 20 and a doorassembly 12 hinging over chassis 20 to hold an infusion tubing whenclosed. Pump casing 10 also includes a lever 100, and an air-in-line(AIL) sensor 14. In some embodiments, AIL sensor 14 may be mounted at abottom end of chassis 20. AIL sensor 14 may include two sensing elements16 a and 16 b (hereinafter, collectively referred to as “sensingelements 16”) disposed on two sides of a slot 18. In some embodiments,pump casing 10 includes a bezel 28 mounted on chassis 20 and configuredto support a shaft 30. A lever 100 hinges on shaft 30, which allowslever 100 to rotate about the axis of shaft 30. In some embodiments,door assembly 12 includes a reinforced rib 115 on an interior wall ofdoor assembly 12 to engage lever 100 as door assembly 12 rotates toclose over chassis 20.

The pump casing 10 further includes a seat 22 shaped to hold infusiontubing 25 and to place the infusion tubing 25 in a gap (e.g., slot 18)formed by the two sensing elements 16 of the air-in-line sensor 14, andwherein the seat 22 comprises a bottom stop 516 (FIG. 5) to stop theinfusion tubing 25 in the air-in-line sensor gap when the door assembly12 is closed.

FIG. 2 illustrates lever 100, driven by door assembly 12 and configuredto place an infusion tubing 25 within AIL sensor 16 at an appropriatedepth on a seat 22, according to some embodiments.

Lever 100 includes a far end 101 configured to engage an infusiontubing, and a pivot end 102 configured to fit onto shaft 30 and to allowlever 100 to rotate about a shaft axis 33. In some embodiments, lever100, further includes a clip 112 to secure lever 100 over shaft 30.

AIL sensor 16 includes a signal (e.g., an ultrasound signal) travelingacross the tubing that includes the infusion fluid). Accordingly,infusion tubing 25 should be seated appropriately so that the ultrasoundsignal in AIL sensor 14 overlaps slot 18 and traverses the fluid.

In some embodiments, chassis 20 further includes a switch 201 toactivate the pump mechanism when lever 100 reaches a fully closedposition upon closing door assembly 12.

FIG. 3 is a close-up perspective view of lever 100, including a capturedspring 310 for automatic unloading when door assembly 12 is opened,according to some embodiments. Pivot end 102 includes a pocket 320 tocapture a spring 310 having a leg 312 protruding outside of pocket 320.Spring 310 is configured to bias lever 100 against door assembly 12. Insome embodiments, lever 100 includes a tab 316 disposed on an outer sideof far end 101 and configured to interface with reinforced rib 115 indoor assembly 12. Also, in some embodiments, lever 100 includes a pusher318 protruding into an inner side of far end 101 and configured tocontact infusion tubing 25 when far end 101 engages infusion tubing 25.In some embodiments, pusher 318 is configured to apply a downwardpressure to infusion tubing 25 when door assembly 12 is closed. In someembodiments, pusher 318 applies pressure until infusion tubing 25 isproperly aligned with sensing elements 16 (cf. AIL sensor 14) disposedon both sides of infusion tubing 25, in slot 18. In some embodiments,pusher 318 comprises a width that fits between the two sensing elementsof the air-in-line sensor.

In some embodiments, far end 101 includes two walls 314 (only onevisible in FIG. 3) projecting downward to engage the infusion tubing,each of walls 314 being taller than pusher 181 (e.g., reaching furtherdown in FIG. 3) to form infusion tubing 25 longitudinally into an arch.In some embodiments, walls 314 include a trough to accommodate infusiontubing 25. Accordingly, walls 314 push infusion tubing 25 to overlapslot 18 between sensing elements 16 of AIL sensor 14 when door assembly12 is closed. In some embodiments, when door assembly 12 is closed,walls 314 in lever 100 enshroud seat 22 and sensing elements 16.Accordingly, far end 101 of lever 100 may also act as a mechanical coverand protection to AIL sensor 14, in some embodiments. In embodiments,spring 310 is configured to bias lever 100 against door assembly 12 whendoor assembly 12 is open and when door assembly 12 is closed.

In some embodiments, lever 100 may be a plastic, injection molded partdesigned with specific geometry to auto insert infusion tubing 25through slot 18 in AIL sensor 14. In some embodiments, lever 100 isspring-loaded with geometric features, e.g., tab 316 in far end 101 thatmate up with door assembly 12 (e.g., reinforced rib 115) such that whendoor assembly 12 is closed, it forces the rotation of lever 100 into aclosed position, capturing and guiding (e.g., through walls 314)infusion tubing 25 into correct position and depth within slot 18. Whendoor assembly 12 is opened, lever 100, automatically opens by the actionof spring 310, thus allowing the user to safely and easily removeinfusion tubing 25.

In some embodiments, actuation of lever 100 through spring 310 leveragesthe closure of door assembly 12, thereby providing forces that pushinfusion tubing 25 in place (e.g., fully inside slot 18).

FIG. 4 illustrates pin 110 attached to bezel 28, and configured tosupport lever 100, according to some embodiments. In some embodimentschassis 20 further includes a groove 410 configured to receive springleg 312.

FIG. 5 illustrates a front view 500 of lever 100 interacting with tubing25 when door assembly 12 is closed, according to some embodiments. Insome embodiments, pusher 318 has a height so as to push infusion tubing25 so far as to overlap with slot 18 forming a sensitive area betweensensing elements 16 of AIL sensor 14.

FIG. 6 illustrates a close-up perspective view of door assembly 12,including reinforced ribs 612 a and 612 b, and guiding rib 115 having aflattened edge 615, according to some embodiments. In some embodiments,door assembly 12 includes a protruding feature 614 having an archedsurface 620, and configured to relieve stress from infusion tubing 25(not shown) when door assembly 12 is closed.

FIG. 7 illustrates an intra-venous pump 70 including pump casing 10,door assembly 12, and chassis 20, according to some embodiments. In someembodiments, pump casing 10 may further include an alarm 701 that isactivated when infusion tubing 25 fails to fully overlap slot 18 whendoor assembly 12 is closed.

FIG. 8 is a flow chart illustrating steps in a method 800 for deliveringa medication to a patient, according to some embodiments. Step 802includes opening a door assembly to expose a pump chassis in an infusionpump, wherein the pump chassis includes a seat adjacent to anair-in-line sensor, and wherein the air-in-line sensor includes twosensing elements disposed on two sides of a gap. Step 804 includesloading an infusion tubing to the infusion pump.

Step 806 includes closing the door assembly over the chassis andallowing a far end of a lever to pivot about a shaft and to push theinfusion tubing into the gap in the air-in-line sensor. In someembodiments, allowing the far end of the lever to pivot about a shaft instep 806 includes moving the door assembly against the chassis until theindicator in the air line sensor indicates that the infusion tubingproperly overlaps the gap. In some embodiments, to push the infusiontubing into the gap in the air line sensor in step 806 includescontacting the infusion tubing with two walls and a pusher in the farend of the lever as the door assembly is closed over the chassis.Further, in some embodiments, to push the infusion tubing into the gapin the air line sensor in step 806 includes contacting a tab disposed onan outer side of the far end of the lever with a reinforced rib on aninner side of the door assembly.

Step 808 includes activating the pump to deliver the medication to thepatient when an indicator in the air-in-line sensor indicates that theinfusion tubing properly overlaps the gap. In some embodiments, step 808includes relieving a stress of the infusion tubing with a protrudingfeature having an arched surface on an inner side of the door assembly.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (e.g.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim. The word“exemplary” is used herein to mean “serving as an example, instance, orillustration.” Any embodiment described herein as “exemplary” is notnecessarily to be construed as preferred or advantageous over otherembodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.” Theterm “some” refers to one or more. All structural and functionalequivalents to the elements of the various configurations describedthroughout this disclosure that are known or later come to be known tothose of ordinary skill in the art are expressly incorporated herein byreference and intended to be encompassed by the subject technology.Moreover, nothing disclosed herein is intended to be dedicated to thepublic regardless of whether such disclosure is explicitly recited inthe above description.

While certain aspects and embodiments of the subject technology havebeen described, these have been presented by way of example only, andare not intended to limit the scope of the subject technology. Indeed,the novel methods and systems described herein may be embodied in avariety of other forms without departing from the spirit thereof. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thesubject technology.

What is claimed is:
 1. A lever, comprising: a far end configured to engage an infusion tubing; a pivot end configured to fit onto a shaft and to allow the lever to rotate about a shaft axis, the pivot end comprising a pocket to capture a spring having a leg protruding outside of the pocket, wherein the spring is configured to bias the lever against an infusion pump door assembly; a tab disposed on an outer side of the far end and configured to interface with the door assembly; and a pusher protruding into an inner side of the far end and configured to contact the infusion tubing when the far end engages the infusion tubing, wherein the pusher is configured to apply a downward pressure to the infusion tubing when the door assembly is closed until the infusion tubing is properly aligned with an air-in-line sensor disposed on both sides of the infusion tubing.
 2. The lever of claim 1, wherein the far end comprises two walls projecting downward to engage the infusion tubing.
 3. The lever of claim 2, wherein each of the two walls are taller than the pusher and configured to form the infusion tubing into an arc.
 4. The lever of claim 2, wherein each of the two walls comprise a trough to accommodate the infusion tubing.
 5. The lever of claim 2, wherein the two walls are configured to push the infusion tubing to overlap a slot of the air-in-line sensor.
 6. The lever of claim 1, wherein the pusher has a height so as to push the infusion tubing so far as to overlap a sensitive area of the air-in-line sensor.
 7. The lever of claim 1, wherein the pusher comprises a width that fits between the two sensing elements of the air-in-line sensor.
 8. The lever of claim 1, further comprising a clip to secure the lever over the shaft.
 9. The lever of claim 8, wherein the shaft is configured to support the clip to hold the lever in place while allowing the lever to rotate freely about the shaft.
 10. The lever of claim 1, wherein the lever is configured to push the infusion tubing into a seat shaped to hold the infusion tubing and to place the infusion tubing in a slot of the air-in-line sensor.
 11. The lever of claim 10, wherein the lever is configured to push the infusion tubing against a bottom stop of the seat to position the infusion tubing in the slot of the air-in-line sensor when the door assembly is closed.
 12. The lever of claim 10, wherein the far end comprises two walls projecting downward and that are configured to enshroud the seat and the air-in-line sensor when the door assembly is closed.
 13. The lever of claim 12, wherein the far end is configured to be a mechanical and protective cover for the air-in-line sensor.
 14. The lever of claim 1, wherein the tab is configured to interface with a reinforced rib on an interior wall of the door assembly.
 15. The lever of claim 1, wherein the spring is configured to bias the lever against the door assembly when the door assembly is open and when the door assembly is closed.
 16. The lever of claim 1, wherein the lever is configured to cause a switch to activate a pumping action when the lever reaches a fully closed position upon closing the door assembly.
 17. The lever of claim 1, wherein the spring is configured to automatically open the lever when the door assembly is opened.
 18. A method of operating an infusion pump, the method comprising: loading an infusion tubing into the infusion pump having the lever of claim 1; closing the infusion pump door assembly to cause the far end of the lever to pivot about the shaft and to cause the pusher to contact and push the infusion tubing into a slot in the air-in-line sensor; and activating the infusion pump when the air-in-line sensor indicates that the infusion tubing is properly aligned within the slot.
 19. The method of claim 18, further comprising activating an alarm when the infusion tubing is not properly aligned within the slot when the infusion pump door assembly is closed.
 20. The method of claim 18, further comprising providing a mechanical and protective cover for the air-in-line sensor by enshrouding the air-in-line sensor with the far end of the lever when the door assembly is closed. 